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Stabilisation and rapid reconstitution of biopharmaceuticals
Improving the reconstitution and increasing the stability of biomolecules using supercritical fluid (SCF) processing
Mechanism of action
Supercritical fluid (SCF) processing of proteins, proteins, monoclonal antibodies, plasmid DNA and other biomolecules
Full description
Although the use of biopharmaceuticals is on the increase, a major challenge for their efficient formulation and design is associated with their inherent lack of room temperature stability during processing or product storage (shelf-life). Many products are marketed as liquid products which need refrigeration or low temperature storage. Whilst conventional precipitation methods as well as freeze and spray drying processes can be used these procedures are expensive and often involve complex operations, therefore new alternatives are required.
Supercritical fluid (SCF) technologies, and the incorporation of stabilising and other regulatory acceptable agents (FDA approved etc) during particle formation have been shown to be a attractive and viable alternative to the aforementioned more conventionally used processes. The SCF process has been proven in many cases, to be able to process room temperature stable, uniform particles that are capable of rapid reconstitution. This is due to a unique processing environment that is virtually free of denaturing sheer forces and surface tension.
It is also possible to create inhalable peptides for systemic delivery. The typical bioavailability in human studies is approximately 18%, prior to optimisation.
Development status
Phase I/II
Patent information
CrystecPharma's intellectual property strategy is to protect products, maintaining its technology platform and scale-up expertise as a trade secret.
Type of business relationship sought
We are keen to work with companies developing large molecule therapeutics who are facing challenges of poor reconstitution, cold chain or stability.
Related reports
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Licensing contact
Company details
CrystecPharma
CrystecPharma applies the latest supercritical fluid (SCF) technologies to improve the design and performance of medicines
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